DEADLINE – May 26, 2024! ACT NOW! Submitt your application to your Notified Body and keep your foot on the gas. Keep all your MDD legacy pr...
Important Announcement: CE-Marking Extensions and Medical Devices in the UK
The UK Government has made a significant announcement concerning CE-marking extensions, and we want to ensure absolute clarity on the matter. However,...
Exciting Trends in MDR/IVDR Transition: A Promising Update for Medical Device Manufacturers
Exciting Trends in MDR/IVDR Transition: A Promising Update for Medical Device Manufacturers We have some fantastic news for all medical device manufac...
Timelines for CE Marked Medical Device Placement in the Great Britain Market: UK MDR 2023 Update
UK MDR Update published! It is finally official! The Medical Devices (Amendment) (Great Britain) Regulations 2023 – statutory instrument 2023 No...
Official Q&A on the extension of the MDR published!
BSI supports its clients with their own FAQ We are pleased to announce that the highly anticipated Q&A clarifying several aspects regarding the la...
Have your say!
EU proposes Master UDI for contact lenses The European Union has introduced a new initiative for a Master Unique Device Identification (UDI) Device ...
Extension of the MDR for legacy devices!
On February 16, 2023, the European Parliament adopted the extension of the transition period for the EU MDR and to extend the validity of certain devi...
New Features and Improvements in EUDAMED
EUDAMED Production v 2.10 has been released with several new features and improvements. Are you ready for the latest and greatest version of EUDAMED P...
Understanding the Clinical Evaluation Consultation Procedure Under EU’s MDR Regulation
Understanding the Clinical Evaluation Consultation Procedure Under EU’s MDR Regulation The EU’s Medical Device Regulation (MDR) has brough...
Handling of Certification Gaps according to MDCG 2022-18
Handling of Certification Gaps according to MDCG 2022-18 Introduction The Medical Device Coordination Group (MDCG) has released a new document that pr...
